Author: kclingan

What are the risks?

The vaginal rings can cause some side effects, such as an allergic
reaction. We do not yet know all the side effects of the vaginal rings. Some, but not all women who used the vaginal rings in other studies have had discharge from the vagina,
vaginal irritation, and discomfort .

VAGINAL RING STUDY

What are the benefits?

You may not benefit directly from taking part in this study. No one knows if the vaginal ring will prevent HIV infection. Information learned from this study may help in the
development of ways to prevent the spread of HIV in the future .

If you are interested in participating or would like more information,
please contact the AMCRS Team at:
205. 996. 4405
Alabama Microbicide Clinical Research Site (AMCRS)
1917 Outpatient/Research Clinic
908 20th Street South
Birmingham, AL 35205

Version 1.0 dated 06 February 2014

Teenage Girls
(age 15-17)
Study of Dapivirine Vaginal Ring in Adolescents

What does the study involve?

What is the purpose of this study?

The main purpose of this study is to find out if a vaginal ring containing a drug called dapivirine is safe and
acceptable for teenage girls to use. Dapivirine is a microbicide, which is a drug or agent being developed to prevent HIV infection. You cannot get HIV from wearing the ring.

Has this drug been tested before in other women and girls?

If you decide to take part in the study, you will be placed into one of two groups: dapivirine ring or placebo ring. Your group will be chosen by chance and you will not know which group you are in. Once assigned to a group, you will be asked to insert a new ring once a month for 3 months. The study includes 6 visits to the clinic, and 2 follow-up phone calls. A brief outline of the study is given below.
Screening Visit $50
Enrollment Visit $75
1-Week Phone Call $25
2-Week Visit $75
4-Week Visit $75
8-Week Visit $75
12-Week Visit $125
13-Week Phone Call $25
Total $525

At the clinic visits, you will receive physical and GYN exams, urine and blood tests, STI testing, and HIV
testing and counseling. You will also be given questionnaires so that
researchers can learn more about your experience with the ring.

Am I qualified to participate ?

We are looking for teenage girls ages 15-17 years old who are healthy and have had sex at least once. You must be on birth control in order to
participate in the study.

The person in charge of this study at UAB is:
Dr. Craig Hoesley
UAB Department of Medicine
Division of Infectious Disease

YES. It is important that you know that vaginal rings containing dapivirine have been tested before in women ages 18-45 and were found to be generally safe. The ring being tested in the study is investigational, which means it has not been
approved by the US Food and Drug
Administration (FDA) .